Amino Acid Composition Reduces Frequency of Common Cold. Results of a Controlled Completely Masked Trial

August 10, 2011 updated by: Kyberg Vital GmbH

Amino Acid Composition Reduces Frequency of Common Cold. Results of a Controlled Randomized Completely Masked Trial

The purpose of this study is to investigate the effectiveness of a dietary supplement with high dosage of amino acids and vitamins in the treatment of acute and chronic infection of pharyngeal area known as common cold. T

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

145

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Oberhaching, Bavaria, Germany, 82041
        • Kyberg Vital - Doris Meister

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

men and women with at least two episodes of common cold and infection of ear, nose and pharyngeal area.

Exclusion Criteria:

  • people with severe infection like pneumonia, patients expecting an in-patient treatment during the trial, pregnant or breast feeding and people not able to understand the procedure of the treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Other: Placebo
placebo contained no amino acids and vitamins and was identical in appearance and solution properties.
Other Names:
  • remedy
Active Comparator: amino acid composition
Dietary supplement: amino acid composition
one single pouch (13g) of amino acid mixture and vitamins diluted into 200 ml of still water. This solution was daily oral taken after a meal.
Other Names:
  • Brand name: aminoplus immun

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
outcome of efficacy
Time Frame: 3 month treatment
For each study day,participants recorded in a diary rectal temperature, symptoms of sneezing, blocked nose or streaming eyes, whether they had problems to swollow and whether they had headache or pain in arms or legs.
3 month treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
outcome of efficacy
Time Frame: 3 month treatment
Secondary outcome variables: feel the patient fit and able-bodied.
3 month treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyberg Vital GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

August 9, 2011

First Submitted That Met QC Criteria

August 10, 2011

First Posted (Estimate)

August 11, 2011

Study Record Updates

Last Update Posted (Estimate)

August 11, 2011

Last Update Submitted That Met QC Criteria

August 10, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Kyb10/09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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